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Rectal Microbicide Development

  • Ian McGowanEmail author
  • Charlene Dezzutti
Chapter
Part of the Current Topics in Microbiology and Immunology book series (CT MICROBIOLOGY, volume 383)

Abstract

The last few years have seen important progress in demonstrating the efficacy of oral pre-exposure prophylaxis, vaginal microbicides, and treatment as prevention as effective strategies for reducing the risk of acquiring or transmitting HIV infection. There has also been significant progress in the development of rectal microbicides. Preclinical non-human primate studies have demonstrated that antiretroviral microbicides can provide significant protection from rectal challenge with SIV or SHIV. Recent Phase 1 rectal microbicide studies have characterized the safety, acceptability, compartmental pharmacokinetics (PK), and pharmacodynamics (PD) of both UC781 and tenofovir gels. The tenofovir gel formulation used in vaginal studies was not well tolerated in the rectum and newer rectal-specific formulations have been developed and evaluated in Phase 1 studies. The PK/PD data generated in these Phase 1 studies may reduce the risk of advancing ineffective candidate rectal microbicides into late stage development. Tenofovir gel is currently poised to move into Phase 2 evaluation and it is possible that a Phase 2B/3 effectiveness study with this product could be initiated in the next 2–3 years.

Keywords

Simian Immunodeficiency Virus Active Pharmaceutical Ingredient Fecal Calprotectin Receptive Anal Intercourse Unprotected Receptive Anal Intercourse 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

RM research has been extensively funded through the National Institute of Allergy and Infectious Diseases, Division of AIDS (5UM1AI068633 and 5U19AI082637) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development as well as the National Institute of Mental Health (5R01HD059533).

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© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.University of Pittsburgh School of MedicinePittsburghUSA

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